This site is intended for healthcare professionals
Abstract digital waveforms in blue and purple
FDA Drug information

Ketoconazole

Read time: 1 mins
Marketing start date: 02 May 2025

Summary of product characteristics


Effective Time

20250312

Version

2

Spl Product Data Elements

Ketoconazole Ketoconazole KETOCONAZOLE KETOCONAZOLE COCO DIETHANOLAMIDE DISODIUM LAURETH SULFOSUCCINATE FD&C RED NO. 40 HYDROCHLORIC ACID IMIDUREA PEG-120 METHYL GLUCOSE DIOLEATE SODIUM CHLORIDE SODIUM LAURETH-3 SULFATE WATER

Application Number

ANDA218559

Brand Name

Ketoconazole

Generic Name

Ketoconazole

Product Ndc

70771-1874

Product Type

HUMAN PRESCRIPTION DRUG

Route

TOPICAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1874-7 Ketoconazole Shampoo, 2% For Topical Application Only 4 FL OZ (120 mL) Rx Only Front Image Back image image back image

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.